RecruitingPhase 4NCT01553214

Improving White Blood Cell Collection From Healthy Donors

Collection of Granulocytes by Apheresis of Healthy Donors Stimulated With Filgrastim (G-CSF) and Dexamethasone


Sponsor

National Institutes of Health Clinical Center (CC)

Enrollment

1,000 participants

Start Date

Dec 31, 2012

Study Type

INTERVENTIONAL

Conditions

Summary

Background: \- White blood cells called granulocytes help the body fight infection. People who have had chemotherapy or bone marrow transplants may have very low numbers of these cells. Transfusions of these cells can help improve the body's ability to fight infection. However, most of the cells are located in the bone marrow or spleen, and are hard to collect from healthy donors. Two drugs, filgrastim and dexamethasone, can help move the cells to the bloodstream to be collected by apheresis. Researchers want to study the best ways to collect these white blood cells. They also want to monitor the effects of the injections and donations on the volunteer donors. Objectives: \- To improve the amount and quality of granulocytes (white blood cells) collected by apheresis for donation. Eligibility: \- Healthy volunteers between 18 and 75 years of age. Design: * Participants will be screened with a physical exam and medical history. Initial blood tests will be done to check for eligibility. * Participants will donate granulocytes by apheresis a maximum of 12 times in 1 year. Donations will not usually be requested more often than every 4 weeks. Donors will be allowed to decline participation at any time. * Participants will have one injection of filgrastim 12 to 24 hours before donation. They will also have two tablets of dexamethasone 12 hours before donation. * White blood cells will be collected through apheresis. The apheresis will last about 2 hours. * Participants will be eligible to donate until they reach their 76th birthday.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study looks at ways to improve the process of collecting white blood cells (granulocytes) from healthy donors who are given medications to boost white cell production. These donations are used to treat patients with severe infections who are not responding to antibiotics. You may be eligible if: - You are between 18 and 75 years of age - You meet standard blood donor eligibility requirements - If you have hypertension, it is well-controlled on medication - If you have a history of peptic ulcer disease, your symptoms are well-controlled You may NOT be eligible if: - You weigh less than 50 kg (110 lbs) - You have a history of coronary heart disease or uncontrolled high blood pressure - You have insulin-dependent diabetes - You have active peptic ulcer disease or a history of iritis/episcleritis - You have sickle cell disease - You are on lithium therapy - You are pregnant or breastfeeding - You have reduced kidney function (eGFR under 45 ml/min) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFilgrastim

Donors shall receive G-CSF 480 mcg as a single 1.6-mL subcutaneous injection 12 to 24 hours prior to donation.

DRUGDexamethasone

Donors shall ingest dexamethasone 8 mg (two 4-mg tablets) orally 12 hours prior to donation.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT01553214